Plexa ICD Lead Registry

• Sponsor: Biotronik, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03103503
• Collaborator: (none)
• Enrollment: 901
• Locations: 28
• Actual Duration (Months): 28.3
• Patients Per Site: 32.2
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.

Condition or Disease	Intervention/Treatment	Phase
Implantable Defibrillator User

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 901 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Plexa ICD Lead Registry
• Actual Study Start Date: May 18, 2017
• Actual Primary Completion Date: Sep 27, 2019
• Actual Study Completion Date: Sep 27, 2019

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects Free From Plexa Lead Related Adverse Events [Up to 2.5 years]

   Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture.

Secondary Outcome Measures

1. Plexa Lead Safety-Individual Adverse Events [Up to 2.5 years]

   Evaluate the individual types of adverse events contributing to primary outcome measure 'Percentage of Subjects Free From Plexa Lead Related Adverse Events'

2. Pacing Threshold Measurements for the Plexa Lead Through Study Termination [Up to 2.5 years]

   Pacing threshold measurements at pulse width of 0.4 for the Plexa leads at completed follow-up visits.

3. Sensing Measurements for the Plexa Lead Through Study Termination [Up to 2.5 years]

   Sensing measurements for the Plexa leads at completed follow-up visits.

4. Pacing Impedance Measurements for the Plexa Lead Through Study Termination [Up to 2.5 years]

   Pacing impedance measurements for the Plexa leads at completed follow-up visits.

5. Shock Impedance for the Plexa Lead Through Study Termination [Up to 2.5 years]

   Shock impedance measurements for the Plexa leads at completed follow-up visits.

6. Percentage of Subjects Free From Protocol Defined Adverse Events [Up to 2.5 years]

   Evaluate the percentage of subjects without a protocol defined and clinical event committee adjudicated adverse event, excluding events included in the primary outcome 'Percentage of Subjects Free From Plexa Lead Related Adverse Events', through study termination. Lead dislodgements, high pacing threshold, failure to capture, and intermittent capture related to the Plexa lead that occurred less than or equal to 30 days after lead implant or a lead revision procedure are included here. The endpoint is analyzed as the adverse event free-rate.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Successfully implanted with a BIOTRONIK ICD or CRT-D compatible system along with the Plexa lead no more than 30 days prior to consent

• Able to understand the nature of the registry and provide informed consent

• Available for follow-up visits on a regular basis at the study site for the expected 5 years of follow-up

• Accepts BIOTRONIK Home Monitoring® concept

• Age greater than or equal to 18 years

Exclusion Criteria:

• Enrolled in any investigational cardiac device trial

• Enrolled in BIOTRONIK's QP ExCELs lead study

• Planned cardiac surgical procedures or interventional measures within the next 6 months

• Expected to receive heart transplantation or ventricular assist device within 1 year

• Life expectancy of less than 1 year

• Patients reporting pregnancy at the time of enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Hospital Research Office	Fairhope	Alabama	United States	36532
2	Jeffrey S Goodman MD	Los Angeles	California	United States	90048
3	Eisenhower Desert Cardiology	Rancho Mirage	California	United States	92270
4	Florida Hospital	Orlando	Florida	United States	32803
5	Advent Health Tampa	Tampa	Florida	United States	33613
6	St. Louis Cardiology Consultants	Alton	Illinois	United States	62002
7	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
8	Heartland Cardiology	Wichita	Kansas	United States	67205
9	Research Integrity LLC	Owensboro	Kentucky	United States	42303
10	Northern Light Cardiology	Bangor	Maine	United States	04401
11	University of Michigan	Ann Arbor	Michigan	United States	48109
12	Metro Health Hospital	Wyoming	Michigan	United States	49519
13	Michigan Heart	Ypsilanti	Michigan	United States	48197
14	St. Louis Heart and Vascular	Saint Louis	Missouri	United States	63122
15	Gateway Cardiovascular Research Center	Saint Louis	Missouri	United States	63128
16	Mercy Clinic Heart and Vascular	Saint Louis	Missouri	United States	63141
17	Mercy Clinic Cardiology	Springfield	Missouri	United States	65804
18	Glacier View Research Institute Cardiology	Kalispell	Montana	United States	59901
19	Deborah Heart and Lung Center	Browns Mills	New Jersey	United States	08015
20	Novant Health	Winston-Salem	North Carolina	United States	27103
21	Sanford Medical Center	Fargo	North Dakota	United States	58102
22	The Ohio State Wexner Medical Center	Columbus	Ohio	United States	43210
23	Toledo Cardiology	Toledo	Ohio	United States	43608
24	The Arrhythmia Institute	Newtown	Pennsylvania	United States	18940
25	Upstate Cardiology	Greenville	South Carolina	United States	29607
26	Carolina Heart Specialists	Lancaster	South Carolina	United States	29720
27	Carolina Cardiology Associates	Rock Hill	South Carolina	United States	29732
28	Cardiovascular Associates Ltd	Virginia Beach	Virginia	United States	23454

Sponsors and Collaborators

• Biotronik, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 1, 2017

More Information

Publications

None provided.

• Responsible Party: Biotronik, Inc.
• ClinicalTrials.gov Identifier: NCT03103503
• Other Study ID Numbers: Plexa Registry
• First Posted: Apr 6, 2017
• Last Update Posted: Oct 14, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	BIOTRONIK Plexa ICD Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
Period Title: Overall Study
STARTED	901
COMPLETED	0
NOT COMPLETED	901

Baseline Characteristics

Arm/Group Title	BIOTRONIK Plexa ICD Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
Overall Participants	901
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.35 (12.59)
Sex: Female, Male (Count of Participants)
Female	237 26.3%
Male	657 72.9%
Race and Ethnicity Not Collected (Count of Participants)
Height (inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [inches]	68.5 (4.0)
Weight (pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pounds]	207.2 (57.0)

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Free From Plexa Lead Related Adverse Events
Description	Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture.
Time Frame	Up to 2.5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BIOTRONIK Plexa ICD Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
Measure Participants	901
Number (95% Confidence Interval) [percentage of participants]	100.00 11.1%

2. Secondary Outcome

Title	Plexa Lead Safety-Individual Adverse Events
Description	Evaluate the individual types of adverse events contributing to primary outcome measure 'Percentage of Subjects Free From Plexa Lead Related Adverse Events'
Time Frame	Up to 2.5 years

Outcome Measure Data

Analysis Population Description

No primary outcome adverse events were reported; therefore, there are no individual events to be analyzed.

Arm/Group Title	BIOTRONIK Plexa ICD Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
Measure Participants	0

3. Secondary Outcome

Title	Pacing Threshold Measurements for the Plexa Lead Through Study Termination
Description	Pacing threshold measurements at pulse width of 0.4 for the Plexa leads at completed follow-up visits.
Time Frame	Up to 2.5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BIOTRONIK Plexa ICD Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
Measure Participants	901
Measure visits with measurement	3714
Mean (Standard Deviation) [V]	0.63 (0.28)

4. Secondary Outcome

Title	Sensing Measurements for the Plexa Lead Through Study Termination
Description	Sensing measurements for the Plexa leads at completed follow-up visits.
Time Frame	Up to 2.5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BIOTRONIK Plexa ICD Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
Measure Participants	901
Measure visits with measurement	3746
Mean (Standard Deviation) [mV]	15.88 (5.56)

5. Secondary Outcome

Title	Pacing Impedance Measurements for the Plexa Lead Through Study Termination
Description	Pacing impedance measurements for the Plexa leads at completed follow-up visits.
Time Frame	Up to 2.5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BIOTRONIK Plexa ICD Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
Measure Participants	901
Measure visits with measurement	3925
Mean (Standard Deviation) [ohms]	567.1 (111.2)

6. Secondary Outcome

Title	Shock Impedance for the Plexa Lead Through Study Termination
Description	Shock impedance measurements for the Plexa leads at completed follow-up visits.
Time Frame	Up to 2.5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BIOTRONIK Plexa ICD Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
Measure Participants	901
Measure visits with measurement	3913
Mean (Standard Deviation) [ohms]	75.1 (13.7)

7. Secondary Outcome

Title	Percentage of Subjects Free From Protocol Defined Adverse Events
Description	Evaluate the percentage of subjects without a protocol defined and clinical event committee adjudicated adverse event, excluding events included in the primary outcome 'Percentage of Subjects Free From Plexa Lead Related Adverse Events', through study termination. Lead dislodgements, high pacing threshold, failure to capture, and intermittent capture related to the Plexa lead that occurred less than or equal to 30 days after lead implant or a lead revision procedure are included here. The endpoint is analyzed as the adverse event free-rate.
Time Frame	Up to 2.5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BIOTRONIK Plexa ICD Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
Measure Participants	901
Number (95% Confidence Interval) [percentage of participants]	95.12 10.6%

Adverse Events

Time Frame	Though study exit or study termination, an average of 1.1 years
Adverse Event Reporting Description	Serious adverse events were defined according to ISO14155.
Arm/Group Title	BIOTRONIK Plexa ICD Lead
Arm/Group Description	Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
All Cause Mortality
	BIOTRONIK Plexa ICD Lead
	Affected / at Risk (%)	# Events
Total	64/901 (7.1%)
Serious Adverse Events
	BIOTRONIK Plexa ICD Lead
	Affected / at Risk (%)	# Events
Total	44/901 (4.9%)
Cardiac disorders
LV lead related high pacing threshold	1/901 (0.1%)	1
LV lead related lead dislodgement	1/901 (0.1%)	1
RV lead related lead dislodgement	12/901 (1.3%)	12
RV lead related other: high defibrillation threshold.no evidence for lead malfunction	1/901 (0.1%)	1
RA lead related lead dislodgement	5/901 (0.6%)	6
RV lead related high pacing threshold	1/901 (0.1%)	1
RV lead related intermittent capture	1/901 (0.1%)	1
RV lead related lead impedance out of range, high	1/901 (0.1%)	1
RV lead related lead undersensing	1/901 (0.1%)	1
General disorders
Twiddler's syndrome	2/901 (0.2%)	3
Pulmonary Emboli	1/901 (0.1%)	1
Infections and infestations
Infection	11/901 (1.2%)	11
Surgical and medical procedures
Hematoma	3/901 (0.3%)	3
Loose set-screw	3/901 (0.3%)	3
Non-healing pocket dehiscence requiring intervention	1/901 (0.1%)	1
Cardiogenic shock during implantation	1/901 (0.1%)	1
Operation wound bleeding	1/901 (0.1%)	1
Venous occlusion associated with the implant procedure	1/901 (0.1%)	1
Other (Not Including Serious) Adverse Events
	BIOTRONIK Plexa ICD Lead
	Affected / at Risk (%)	# Events
Total	12/901 (1.3%)
Cardiac disorders
LV lead related extracardiac stimulation	1/901 (0.1%)	1
LV lead related lead impedance out of range, high	1/901 (0.1%)	1
RV lead related lead dislodgement	1/901 (0.1%)	1
RV lead related other: positional atrial undersensing	1/901 (0.1%)	1
RA lead related lead dislodgement	1/901 (0.1%)	1
RA lead related no capture	2/901 (0.2%)	2
Skin and subcutaneous tissue disorders
Skin erosion	1/901 (0.1%)	1
Surgical and medical procedures
Hematoma	2/901 (0.2%)	2
Non-healing pocket dehiscence requiring intervention	1/901 (0.1%)	1
Slow wound healing, no sign for infection	1/901 (0.1%)	1
Thrombosis	1/901 (0.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.